U.S. FDA Issued Warning Letters About Misbranded Mifepristone And Misoprostol

April 11, 2019

In March, the U.S. Food and Drug Administration (FDA) issued warning letters to AidAccess.org and Rablon after an examination of websites run by both companies were found them to be selling misbranded and unapproved new drugs. Specifically, AidAccess.org and Rablon, an online pharmacy network with at least 87 websites, sold combination packs of mifepristone and misoprostol on their websites. The FDA approved both drugs for the U.S. market, but there is no approved combination pack.

Mifepristone and misoprostol both received approval from the FDA in 2000, but the drugs are only distributed by certified healthcare providers at a doctor’s office, clinic or hospital. Due to the risks associated with both medications, the FDA placed both drugs in their Risk Evaluation and Mitigation Strategy (REMS) program. According to the FDA, REMS is “a safety strategy to manage a known or potential serious risk associated with a medicine and to enable patients to have continued access to such medicines by managing their safe use.”

Mifepristone labels have a boxed warning that serious or even life-threatening adverse effects, such as serious infections and prolonged heavy bleeding, can occur after taking this medication. According to a 2013 study from the Guttmacher Institute, 39% of misoprostol users in Mexico had complications requiring additional treatment after taking the drug primarily due to dosage errors. In an interview with The Atlantic, Luvezlia Carreon, a former patient advocate for McAllen’s Whole Women’s Health in Texas, said that she saw many patients who had taken improper dosages of misoprostol. “A lot of patients said that they would take the whole bottle and they would tell me they took 28 pills,” she said. “I hear different ways of taking these pills. It’s shocking each time.”

While AidAccess.org’s website states that the organization is a private initiative by a dedicated team of medical doctors and activists, less is known about Rablon and its many websites. In addition to the pills sold on Rablon’s websites being non-FDA-approved, the warning letter from the FDA noted that adequate directions on the proper usage of the pills were not included. The FDA took action against both AidAccess.org and Rablon because of the “inherent risk” posed to consumers by the pills they sold.

The warning letter gave the recipients 15 working days to correct any violations or supply the FDA with a reason why action was unable to be taken within that time frame. As of the beginning of April, AidAccess.org and several of the Rablon websites checked still sold the combination packs.